510(k) · Cleared

Cleared

Model Hse-5M Microwave Surgery Equipment/Microtaze

K864413510(k) TraditionalCleared Dec 9, 198629-day reviewClass II21 CFR 876.4300

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cooper Lasersonics, Inc. · KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

Cleared on Dec 9, 1986 after a 29-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 68 later devices descend from it.

Decided: Dec 9, 1986
Review: 29 days
Class: Class II
Product code: KNS
Recalls: None
Predicates: 0

68 later devices descend from it, 1 citing it directly.

This deviceK864413 Model Hse-5M Microwave Surgery Equipment/MicrotazeCooper Lasersonics, Inc. · 1986
Descendant · cites it directly · 67 of its ownK011676 Vivawave Microwave SystemVivant Medical, Inc. · 2002 · Recalled
Descendant · 2 generations on · 50 of its ownK053535 Vivawave Microwave Ablation SystemValleylab · 2006
Descendant · 2 generations on · 41 of its ownK070023 Microsurgeon Microwave Tissue Ablation Device, Model Mtad-100Microsurgeon, Inc. · 2007
Descendant · 3 generations on · 39 of its ownK100744 Certus 140 Microwave Ablation System and Accessories, Model Certus 140Neuwave Medical, Inc. · 2010
Descendant · 4 generations on · 38 of its ownK113237 Certus 140 2.45GHZ Ablation SystemNeuwave Medical, Inc. · 2012

Showing 5 of 68 descendants. See all descendants

Descendants cleared per year

2002high 8 (2024) · low 0 (2005)2026

Most influential descendants

Showing 5 of 68 · See all

K011676Vivawave Microwave SystemVivant Medical, Inc. · 2002 · cites it directly67descendants
K053535Vivawave Microwave Ablation SystemValleylab · 2006 · 2 generations on50descendants
K070023Microsurgeon Microwave Tissue Ablation Device, Model Mtad-100Microsurgeon, Inc. · 2007 · 2 generations on41descendants
K100744Certus 140 Microwave Ablation System and Accessories, Model Certus 140Neuwave Medical, Inc. · 2010 · 3 generations on39descendants
K113237Certus 140 2.45GHZ Ablation SystemNeuwave Medical, Inc. · 2012 · 4 generations on38descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K864413	Model Hse-5M Microwave Surgery Equipment/Microtaze	Cooper Lasersonics, Inc.	1986	—
+1	K011676	Vivawave Microwave System	Vivant Medical, Inc.	2002	1
+2	K053535	Vivawave Microwave Ablation System	Valleylab	2006	—
+2	K070023	Microsurgeon Microwave Tissue Ablation Device, Model Mtad-100	Microsurgeon, Inc.	2007	—
+3	K100744	Certus 140 Microwave Ablation System and Accessories, Model Certus 140	Neuwave Medical, Inc.	2010	—
+4	K113237	Certus 140 2.45GHZ Ablation System	Neuwave Medical, Inc.	2012	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	3	0
2004	1	0
2006	2	0
2007	2	0
2008	2	0
2009	4	0
2010	2	0
2011	1	0
2012	2	0
2013	2	0
2014	1	0
2015	5	0
2016	4	0
2017	2	0
2018	3	0
2019	2	0
2020	6	0
2021	3	0
2022	1	0
2023	7	0
2024	8	0
2025	2	0
2026	2	0

FIG. 1 — Lineage of K864413, 1986–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KNS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new KNS device

#1 K241271 Aqua Medical RF Vapor Ablation Systemscore 17.2 · 20 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (68)

See all 68

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K011676	Vivawave Microwave System	Vivant Medical, Inc.	2002	67

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K011676 (Vivant Medical, Inc., 2002) has gone furthest, with 67 descendants of its own.

How does its category compare?

All KNS devices

KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KNS

11in 2025

2007high 11 (2025) · low 1 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KNS

171in 2025

2007high 252 (2015) · low 30 (2016)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KNS

14in 2024

2007high 41 (2021) · low 0 (2010)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KNS

1,504in 2025

2007high 1,533 (2024) · low 164 (2007)2025

MAUDE reports naming product code KNS, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	1	—	3	164
2008	3	61	5	587
2009	3	212	2	1,027
2010	4	168	0	908
2011	1	—	2	860
2012	2	—	0	848
2013	2	—	0	449
2014	1	—	0	405
2015	3	252	0	406
2016	3	30	6	457
2017	3	48	1	446
2018	5	62	0	563
2019	7	66	0	668
2020	4	212	0	906
2021	4	139	41	814
2022	3	182	0	913
2023	9	83	0	976
2024	3	198	14	1,533
2025	11	171	0	1,504
2026	2	—	4	—

https://510kreport.com/device/K864413 · printed Nov 5, 2026

Cite this page

510(k) Report. “K864413: Model Hse-5M Microwave Surgery Equipment/Microtaze.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K864413

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026